Four artemisinin-based treatments in African pregnant women with malaria

Autor: Jean-Pierre Van Geertruyden, Prosper Gbekor, Joyce Mulenga, Modest Mulenga, Joris Menten, Umberto D'Alessandro, Maminata Traoré-Coulibaly, Michael Nambozi, Harry Tagbor, Theonest K. Mutabingwa, Divine Pekyi, Marc Christian Tahita, Innocent Valea, Céline Schurmans, Kamala Thriemer, Gertrude Kalanda, Victor Mwapasa, Yves Claeys, Raffaella Ravinetto, Akua A. Ampromfi, Linda Kalilani-Phiri, Jean-Bertin Bukasa Kabuya, Maaike De Crop, Chantal Van Overmeir, Sebastian Hachizovu, Halidou Tinto, Gifty Antwi, Mwayiwawo Madanitsa
Přispěvatelé: PREGACT Study Grp, PREGACT Study Group
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Adult
medicine.medical_specialty
Nausea
030231 tropical medicine
Population
Plasmodium falciparum
Polymerase Chain Reaction
law.invention
03 medical and health sciences
Antimalarials
Young Adult
0302 clinical medicine
Randomized controlled trial
law
Pregnancy
Internal medicine
parasitic diseases
medicine
Humans
030212 general & internal medicine
Artemether
Malaria
Falciparum
Adverse effect
education
education.field_of_study
Fluorenes
business.industry
Artemether
Lumefantrine Drug Combination
Pregnancy Outcome
Amodiaquine
General Medicine
medicine.disease
Artemisinins
Surgery
Drug Combinations
Clinical research
Ethanolamines
Pregnancy Complications
Parasitic
Africa
Vomiting
Quinolines
Female
Human medicine
medicine.symptom
business
Research Article (New England Journal of Medicine)
Malaria
medicine.drug
Zdroj: The New England journal of medicine
Malawi medical journal
ISSN: 0028-4793
1995-7262
Popis: BACKGROUND Information regarding the safety and efficacy of artemisinin combination treatments for malaria in pregnant women is limited, particularly among women who live in sub-Saharan Africa. METHODS We conducted a multicenter, randomized, open-label trial of treatments for malaria in pregnant women in four African countries. A total of 3428 pregnant women in the second or third trimester who had falciparum malaria (at any parasite density and regardless of symptoms) were treated with artemether-lumefantrine, amodiaquine-artesunate, mefloquine-artesunate, or dihydroartemisinin-piperaquine. The primary end points were the polymerase-chain-reaction (PCR)-adjusted cure rates (i.e., cure of the original infection; new infections during follow-up were not considered to be treatment failures) at day 63 and safety outcomes. RESULTS The PCR-adjusted cure rates in the per-protocol analysis were 94.8% in the artemether-lumefantrine group, 98.5% in the amodiaquine-artesunate group, 99.2% in the dihydroartemisinin-piperaquine group, and 96.8% in the mefloquine-artesunate group; the PCR-adjusted cure rates in the intention-to-treat analysis were 94.2%, 96.9%, 98.0%, and 95.5%, respectively. There was no significant difference among the amodiaquine-artesunate group, dihydroartemisinin-piperaquine group, and the mefloquine-artesunate group. The cure rate in the artemether-lumefantrine group was significantly lower than that in the other three groups, although the absolute difference was within the 5-percentage-point margin for equivalence. The unadjusted cure rates, used as a measure of the post-treatment prophylactic effect, were significantly lower in the artemether-lumefantrine group (52.5%) than in groups that received amodiaquine-artesunate (82.3%), dihydroartemisinin-piperaquine (86.9%), or mefloquine-artesunate (73.8%). No significant difference in the rate of serious adverse events and in birth outcomes was found among the treatment groups. Drug-related adverse events such as asthenia, poor appetite, dizziness, nausea, and vomiting occurred significantly more frequently in the mefloquine-artesunate group (50.6%) and the amodiaquine-artesunate group (48.5%) than in the dihydroartemisinin-piperaquine group (20.6%) and the artemether-lumefantrine group (11.5%) (P
Databáze: OpenAIRE
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